Project Manager I, Ophthalmology

Fortrea is seeking an Ophthalmology Clinical Project Manager I to join their FSO team. This role involves managing the end-to-end lifecycle of clinical projects, ensuring they are completed on time and within budget while meeting customer needs and adhering to regulatory requirements.

Responsibilities:

• Assist in the leadership of the core project team, as directed by team leadership to facilitate their ability to lead extended cross-functional project teams. Assist in the successful design, implementation, tracking and maintenance of project plans for assigned projects. Assist in ensuring that all staff allocated to assigned projects adheres to professional standards and SOPs. The Project Manager will take accountability for driving project performance while meeting customer needs and maintaining operational excellence. This includes the maintenance of timelines and tracking project progress against contracted deliverables
• Under the direction of team leadership, proactively lead quality control and risk assurance activities to ensure project deliverables are met according to regulatory, internal, and client requirements. Participate in the identification, tracking and maintenance of projects, financial and quality risks using appropriate data sources, dashboards, and risk management strategies. Adheres to project governance and issue escalation pathways, ensuring that project plans are in place to address identified risk while adhering to professional standards, SOPs, client, and regulatory requirements
• Fosters a positive client experience by serving as client primary contact for areas assigned by Project Leadership. Engages in communication and collaboration with the client and project teams across a matrixed, multi-cultural, environment. Participates in the development of project strategy in collaboration with relevant departments
• Assist project team members and key stakeholders to effectively manage budget, resources, and scope. Participated in forecasting project revenue and managing project costs in adherence to the budget. Assist in the management and tracking of project resource needs and contribute to contingency planning for key resources. Ensures that resource projections are accurate and visible to resourcing teams, proactively escalating resource constraints and challenges. Identify timely scope changes against contract to assist in the change order process
• Facilitates positive communication and teamwork. Develops and mentors more junior team members and provides feedback as needed to respective line managers
• All other duties as needed or assigned

Requirements:

• 4+ years of global project coordination experience
• mandatory experience in ophthalmology
• University/college degree (life science preferred) or certification in a related allied health profession (i.e., nursing, medical or laboratory technology) from an appropriately accredited institution
• In lieu of the above requirement, candidates with five (5) or more years of relevant clinical research experience in pharmaceutical, CRO industries or experience in a health care setting will be considered
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements
• Minimum of three (4) years of relevant clinical research experience in a pharmaceutical company/CRO
• In lieu of the above requirements, candidates with greater than four (4) years supervisory experience in a health care setting of which two (2) years clinical research experience (including monitoring) in the pharmaceutical or CRO industries will be considered
• Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
• Demonstrated experience managing or supporting ophthalmology clinical trials, with strong working knowledge of ocular indications, assessment methodologies, and retinal (posterior segment) disease
• Advanced computer skills (e.g., Microsoft Word, Excel, Project, Access, and Power Point)
• Ability to work with minimal supervision
• Excellent verbal and written communication skills
• Ability to set clear expectations for junior staff on projects
• Ability to resolve project-related problems and prioritizes workload for self and team
• Demonstrated organizational skills and the ability to prioritize multi-tasks
• Ability to understand and work with financial information
• Basic knowledge of project management processes
• Demonstrated ability to work within a matrix system
• Local project coordination and/or project management experience
• Proven experience managing global clinical trials across multiple regions, with an understanding of cross-functional and cross-cultural considerations